Kornimate/medical-research-clean huggingface dataset:
gut microbiota and radiotherapy

Conditions: Lung Tumor

Summary: a pilot, single arm, single center study to determine the feasibility of obtaining stool samples from adult patients receiving sbrt to a lung tumor, if sbrt induces changes in the gut microbiota and to obtain preliminary data about possible correlation of baseline composition and changes in gut microbiota with tumor response, local control, and development of pneumonitis/other side effects.


Eligibility criteria:
inclusion criteria: * patient is planned to receive stereotactic body radiotherapy (sbrt) to a lung lesion (either presumed or biopsy-proven nsclc * age 18 years old or older * patient capable of giving informed consent exclusion criteria * use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration * active infection with oral temperature \>100°f * use of corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration * use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. chemotherapy cannot begin before the collection of the 30-day post treatment sample (s4). * confirmed or suspected hiv, hbv or hcv * chronic constipation (bowel movements less frequent than every other day) * active uncontrolled gastrointestinal disorders such as inflammatory bowel disease, moderate/severe irritable bowel syndrome, persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, clostridium difficile infection (recurrent) or helicobacter pylori infection (untreated) * major surgery of the gi tract, with the exception of cholecystectomy and appendectomy, in the past five years. any major bowel resection at any time * patients on anti-diarrheal medications * patients on probiotics

Keywords: stereotactic body radiotherapy sbrt
lidocaine as an anesthetic adjuvant in liver and gastric laparoscopic surgery

Conditions: Pain, Postoperative

Summary: the aim is to analyze the effect of intravenous lidocaine administration on postoperative opioid use in patients undergoing upper abdominal cancer surgery. specifically, those patients undergoing gastric cancer surgery and liver cancer surgery using a laparoscopic approach

in a recent cochrane library review, despite the apparent positive results reported by intravenous administration of lidocaine as a perioperative analgesic adjuvant, the quality of the evidence is low, since the studies carried out to date present small samples, great variability in the designs and different surgical techniques studied. more studies will be needed to help improve the grade and quality of evidence in the management of acute postoperative pain and its role in opioid sparing, an especially beneficial effect in tumor pathology for this reason, the investigators have designed a randomized, double-blind, phase iv clinical trial with two treatment arms, parallel groups, in which 96 patients who underwent liver and gastric cancer surgery through laparoscopic approach participated. this study will include 2 different population groups: patients undergoing liver cancer surgery and patients undergoing gastric cancer surgery

Eligibility criteria:
inclusion criteria: * men and women over 18 years of age scheduled for gastric or liver cancer surgery through a laparoscopic approach at the university of girona dr josep trueta. * accept and sign the informed consent exclusion criteria: * decline participating in the study at any stage of its development. * history of allergic or adverse reactions to amide-type anesthetics. * pregnancy or lactation period * diagnosis of child-pugh stage b or c liver failure. * acute renal failure (gfr \<60 ml / min). * concomitant treatment with opioids for chronic pain. * any condition that, in the clinical judgment of the researchers, may interfere with the object of the research.
cyber disease management: using the world wide web to share the medical record with patients at home

Conditions: Diabetes Mellitus, Type 2

Summary: this is a 12-month randomized, controlled trial of a web-based diabetes co-management module among type 2 patients at the university of washington's roosevelt general internal medicine clinic.

we will conduct a randomized controlled trial to determine whether a fully computerized, diabetes mellitus (dm) disease-management module (known as cyber-dm) can improve the quality of adult diabetes care. the module will be web-based, include a graphical html "front end" user interface, and will be incorporated into each patient's existing web-based electronic medical record --the medical information networked database (mind) repository at the university of washington academic medical centers. this web site will include five components that will enable patients to interact asynchronously from their homes with their clinic-based providers: 1. an integrated view of their actual medical record as it relates to diabetes care that can generate customized patient education materials. 2. real-time clinical reminders of the need to obtain preventive services such as hba1c, urine-protein and cholesterol determinations, and retinal examinations. 3. an electronic version of the sdmtm diabetes-care algorithms indicating where on the "road-map" to adequate control they currently stand treatment-wise. 4. the ability to download glucometer readings and medication-use information from home directly into the mind repository. 5. secure email communication between patients, their primary care physicians, and clinic staff. a total of 80-85 diabetic patients who are regular utilizers of the uw's general internal medicine clinic and who have home internet access will be randomized to the experimental and control arms of the trial. control subjects will receive usual care. we hypothesize that use of cyber-dm will increase compliance with guideline-indicated care processes, improve glycemic control, and reduce utilization costs. a trial this size would have the statistical power to detect a change in hba1c of 0.50%. secure socket layer technology, session specific "cookie" files, and a custom database application that manages logins/passwords and audits all accesses to the system will provide security for this information tool.

Eligibility criteria:
inclusion criteria: * computer and internet access at home * receiving care for type 2 diabetes at the university of washington, general internal medicine clinic, roosevelt exclusion criteria: * non-english speaking

Keywords: diabetes health education information technology disease management internet patient education
affect management group for adult survivors of childhood trauma

Conditions: Stress Disorders, Post-Traumatic

Summary: problems of self regulation, e.g. emotional dysfunction, represent a core symptom of adult patients with traumatic childhood experiences. the study intends to evaluate the efficiency of a 14-week group therapy for adult survivors of relational trauma in childhood. main interventions are psychoeducation about the sequelae of childhood trauma, teaching of skills for affect regulation and techniques for activating resources. the hypothesis is that the group therapy significantly improves the participant's capacity in emotion management and self-soothing.

problems of self regulation, e.g. emotional dysfunction, represent a core symptom of adult patients with traumatic childhood experiences. since sufficient capacity for self soothing and emotional regulation are essential for trauma exposure, modern trauma therapy concepts are phase-oriented, beginning with working on "stabilization". the study intends to evaluate the efficiency of a 14-week group therapy for adult survivors of relational trauma in childhood. main interventions are psychoeducation about the sequelae of childhood trauma, teaching of skills for affect regulation and techniques for activating resources. inclusion criteria are clinical significant problems with self-regulation and the presence of childhood trauma. outcome measures are based on self-rating questionnaires, clinical interviews and an experimental computer-task at timepoint pre-, post- and 3-month-follow-up. there is no control condition in the pilot-study phase.

Eligibility criteria:
inclusion criteria: * adults with moderate to severe relational trauma in childhood (emotional, sexual or physical abuse, emotional or physical neglect) * dsm-iv diagnosis of posttraumatic stress disorder exclusion criteria: * severe dissociation * environmental safety problems * ongoing enmeshment with perpetrators * psychotic disorders * severe depression * acute suicidality * substance abuse * severe cognitive decline

Keywords: psychotherapy, group stress disorders, post-traumatic ambulatory care
study of hpn536 in patients with advanced cancers associated with mesothelin expression

Conditions: Advanced Cancers Associated With Mesothelin Expression

Summary: an open-label, phase 1/2a study of hpn536 as monotherapy to assess the safety, tolerability and pk in patients with advanced cancers associated with mesothelin expression.(phase 2 portion of the study was not conducted.)


Eligibility criteria:
1. one of the following progressive advanced or metastatic cancers: 1. epithelial ovarian, fallopian tube, or primary peritoneal cancer that is platinum refractory or platinum resistant 2. pancreatic adenocarcinoma that is locally advanced, and now with progressive disease on or after front-line treatment 3. malignant mesothelioma with epithelioid histology, pleural or peritoneal 2. for part 2 only - measurable disease according to recist v1.1 for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, pancreatic adenocarcinoma, and peritoneal mesothelioma, and mrecist v1.1 for patients with pleural mesothelioma 3. available archival tissue sample, or fresh biopsy tissue sample must be obtained prior to enrollment. for part 2 only- a fresh biopsy tissue sample is required. 4. adequate bone marrow function, including: 1. absolute neutrophil count (anc) ≥1500/mm3 or ≥1.5 x 109/l 2. platelets ≥100,000/mm3 or ≥100 x 109/l 3. hemoglobin (hgb) ≥9 g/dl 5. adequate renal function, including estimated creatinine clearance ≥30 ml/min 6. adequate liver function, including: 1. total serum bilirubin ≤1.5 x upper limit of normal (uln) unless the patient has documented gilbert syndrome in which case the maximum total serum bilirubin should be \<5 mg/dl 2. aspartate and alanine transaminase (ast and alt) ≤2.5 x uln or ast/alt ≤5 x uln for patients with liver metastases 7. serum albumin ≥30 mg/ml key exclusion criteria: 1. brain metastases unless previously treated. patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, and have no evidence of new or enlarging brain metastases 2. evidence of retroperitoneal fibrosis, mesothelial surface (pleura, pericardium, peritoneum) thickening of ≥4 mm; significant or increasing pleural/pericardial effusions, ascites or pericarditis at baseline deemed unrelated to the underlying malignancy based on computed tomography (ct), magnetic resonance imaging (mri), or echocardiogram (echo); or prior history of pleurodesis, retroperitoneal fibrosis or mediastinal fibrosis. 3. previous grade 3/4 infusion or hypersensitivity reaction (not immunotoxicity) to treatment with another monoclonal antibody. 4. for patients with tumor types other than pleural mesothelioma: ascites requiring \>1 paracentesis for therapeutic purposes (i.e., not for diagnosis) within 1 month prior to cycle 1 day 1.
thyroid function of pediatric subjects following isovue® administration

Conditions: Hypothyroidism

Summary: this is a phase iv prospective, multicenter, observational study to estimate the proportion of subjects 0 to 3 years of age who develop abnormal thyroid function after exposure to intravascular administration of isovue for the required radiologic procedure as part of their standard of care.


Eligibility criteria:
inclusion criteria: * is male or female from 0 to 3 years of age; * is scheduled to undergo a radiologic examination that requires intravascular administration of isovue as part of his/her standard of care; * has normal baseline thyroid function tests (tsh, total t3, total t4, and ft4) performed at a local laboratory with blood sample obtained within one week prior to isovue administration; * written informed consent is obtained from the subject's parent(s) or legally acceptable representative(s) (according to local regulations) who are willing to comply with the protocol requirements. exclusion criteria: * has any known allergy to one or more of the ingredients of isovue; * has been diagnosed with congenital hypothyroidism; * has undergone radiation treatments to the head or neck; * is currently on thyroid replacement therapy; * is on therapy with dopamine or any treatment which may affect the thyroid function testing results; * has been exposed to any topical iodinated product within 30 days prior to enrollment in the present study; * has been exposed to an iodinated contrast agent within 1 year prior to enrollment in the present study, including any administration of iodinated contrast agents during placement of a central line; * has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.

Keywords: hypothyroidism isovue iodinated contrast agent
study to compare triple therapy (oral treprostinil, ambrisentan, and tadalafil) with dual therapy (ambrisentan, tadalafil, and placebo) in subjects with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: this is a multicenter, randomized (2:1 oral treprostinil: placebo), double-blind, placebo-controlled study in subjects with pulmonary arterial hypertension (pah) who are currently receiving background dual therapy (ambrisentan, tadalafil) for at least 30 days at randomization for their pah. once randomized, subjects will return for 5 study visits up to week 28 during the blinded period. after the week 28 visit, eligible subjects will transition to the open-label period of the study for up to 20 weeks.


Eligibility criteria:
inclusion criteria: 1. between 18 and 79 years of age, inclusive 2. pah that is idiopathic / heritable, pah associated with connective tissue disease, hiv infection, repaired congenital systemic-to-pulmonary shunts (repaired \> 1 year), or appetite suppressant / toxin use 3. receiving dual therapy (ambrisentan and tadalafil) 4. previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of pah exclusion criteria: 1. nursing or pregnant 2. pah due to conditions other than noted in the above inclusion criteria 3. received pah-specific drug therapy for \>2 years 4. history of uncontrolled sleep apnea, severe liver disease, severe renal impairment, left sided heart disease, uncontrolled systemic hypertension 5. participated in an investigational drug or device study within 90 days prior to signing consent.

Keywords: pah oral treprostinil dual therapy 6 minute walk test
the use of the hormone kisspeptin in 'in vitro fertilisation' (ivf) treatment

Conditions: Infertility

Summary: we want to find out if kisspeptin is successful in stimulating oocyte maturation when it is used as a 'trigger' injection during ivf therapy for infertility.

participants in the study will have a standard gonadotrophin releasing hormone (gnrh) antagonist ivf cycle, but instead of having a trigger injection of hcg (human chorionic gonadotrophin) they will be randomised to receive one of 4 doses of kisspeptin injection. oocytes will be retrieved and graded by an embryologist to see whether or not they have matured. the reproductive hormones luteinising hormone, follicle stimulating hormone, oestradiol and progesterone will also be measured

Eligibility criteria:
inclusion criteria: * aged 18 - 34 years * body mass index between 18 and 29 kg/m2 * stable body weight for at least 3 months * normal early menstrual cycle follicular phase serum fsh concentration * serum anti-mullerian hormone (amh) \> 40pmol/l * no more than one previous ivf treatment cycle * both ovaries intact exclusion criteria: history of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the volunteer * without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study * treatment with an investigational drug within the preceding 2 months * donated blood during the preceding 3 months or intention to do so before the end of the study * previous poor response to ivf treatment

Keywords: kisspeptin infertility in vitro fertilisation
serrated polyp detection rate between carbon dioxide and air insufflation

Conditions: Serrated Polyp

Summary: sessile serrated adenomas are characterized by their flat shape and the presence of a yellow mucus cap overlying the lesion. these morphological features may account for their diagnostic difficulty during colonoscopy. missed proximal sessile serrated adenomas are regarded as an important cause for interval cancers in the right colon and emphasize the importance of developing quality measures intended to enhance their detection. there is only one single-center retrospective cohort study on the impact of carbon dioxide insufflation on the detection of serrated polyps during colonoscopy. the investigators designed a randomized, controlled trial to compare the effect of carbon dioxide insufflation vs. room air insufflation on serrated polyp detection rate.


Eligibility criteria:
inclusion criteria:patients 45-75-years-old who underwent a colonoscopy - exclusion criteria:polyposis syndrome, inflammatory bowel disease, previous colorectal operation -
effects of calorie restriction on accumulation of old, modified proteins in abdominally obese adults

Conditions: Insulin Resistance

Summary: this study is being done to understand the effects of calorie restriction and weight loss on muscle protein metabolism in adult men and women.


Eligibility criteria:
inclusion criteria: * healthy * bmi will be between 30 kg/m2 - 38 kg/m2 and waist circumference for women ≥ 88 cm and men ≥ 104 cm * age 45 to 65 years. * male and female exclusion criteria: * active coronary artery disease * bmi \ 2 times per week for 30 minutes or longer) * smoking * medications known to affect muscle metabolism (beta blockers) * renal failure (serum creatinine \> 1.5mg/dl) * chronic active liver disease (ast and alt \> 3 times normal) * fasting blood glucose \> 126 mg/dl * anti-coagulant therapy (warfarin/heparin)

Keywords: insulin resistance abdominal obesity calorie restriction
validation of an oncology-specific instrument to measure care coordination

Conditions: Oncology

Summary: the overarching goal of the project is to use a mixed-methods research design to assess the validity of a new instrument developed to assess cancer patients' perceptions of care coordination across varied care settings.

this proposed cancer care delivery research project aims to validate a new instrument (cci; cancer care coordination instrument) designed to assess cancer patients' perceptions of care coordination. care coordination (cc) is important for all patients, and it is especially important for cancer patients as they have complex episodes of care, multi-disciplinary interventions, prolonged duration of care, and an overall high symptom burden. further, cc is critical for cancer patients due to several transition points between stages of care (diagnosis, treatment, survivorship, and end of life), varied settings of care (inpatient, ambulatory), and multiple physicians (medical, surgical, radiation oncologists) and other healthcare providers (e.g., oncology nurses, primary care physicians, physicians/nurses' assistants) providing care. a cci validated in ethnically/racially diverse samples can be utilized to identify potential targets for intervention and improvement in cc for specific populations and to reduce or eliminate the disparities in cancer health outcomes. validation of the cci under this proposal will have widespread applicability to oncology care across varied practice environments and will form a foundation for the creation of similar tools for other chronic and complex conditions.

Eligibility criteria:
inclusion criteria: * active therapy for cancer, defined as a minimum of three exams or therapy visits over a preceding three-month period. * participant is willing and able to give informed consent for participation in the study. exclusion criteria: -

Keywords: active therapy
boost to brittle bones - stem cell transplantation for treatment of brittle bones

Conditions: Osteogenesis Imperfecta

Summary: an exploratory, open label, multiple dose, phase i/ii trial (n=15) evaluating safety and efficacy of intravenous and intraosseous infusion of allogeneic expanded fetal mesenchymal stem cells (msc) for the treatment of severe osteogenesis imperfecta (oi) compared with historical and untreated prospective controls.


Eligibility criteria:
(i)inclusion criteria treatment group 1. parent's/legal guardian's signed informed-consent form 2. clinical diagnosis of oi type iii or iv and 3. molecular diagnosis of oi (glycine substitution in the collagen triple-helix encoding region of either the col1a1 or col1a2 gene) 4. age between 1 to 4 years 5. bp treatment initiated before inclusion 6. parent/legal guardian over 18 years of age (ii)inclusion criteria prospective untreated control group and historical control group: 1. parent's/legal guardian's signed informed-consent form 2. clinical and molecular diagnosis of oi (glycine substitution in the collagen triple-helix encoding region of either the col1a1 or col1a2 gene) 3. age between 4 to 8 years 4. parent/legal guardian over 18 years of age (iii)exclusion criteria treatment group prospective and historical control group: 1. existence of other known disorder that might interfere with the treatment (such as severe malformations, congenital heart defect, hypoxic encephalopathy (l-lll), neurological problems, immune deficiencies, muscle diseases, syndromes) diagnosed by clinical examination 2. any contraindication for invasive procedures such as a moderate/severe bleeding tendency or contagious infections 3. abnormal karyotype or other confirmed genetic syndromes 4. oncologic disease 5. inability to comply with the trial protocol and evaluation and follow-up schedule 6. inability to understand the information and to provide informed consent

Keywords: oi, brittle bone disease hereditary bone fragility